FDA Approves Moxidectin for the Treatment of River Blindness
MELBOURNE, GENEVA, and NEW YORK - June 13, 2018 -- Medicines Development for Global Health (MDGH) and the World Health Organisation Special Programme for Research and Training in Tropical Diseases (TDR) announced today that the United States (U.S.)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 13, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Genentech ’s Avastin (bevacizumab) Plus Chemotherapy as a Treatment for Women With Advanced Ovarian Cancer Following Initial Surgery
South San Francisco, CA -- June 13, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Avastin ® (bevacizumab) in combination with chemotherapy... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 13, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Keytruda (pembrolizumab) for Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
KENILWORTH, N.J.--(BUSINESS WIRE) June 13, 2018 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, the company ’s anti-PD-1 therapy, for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 13, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1
KENILWORTH, N.J.--(BUSINESS WIRE) June 12, 2018 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, the company ’s anti-PD-1 therapy, for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 12, 2018 Category: Drugs & Pharmacology Source Type: news

Genentech Announces FDA Approval for Venclexta Plus Rituxan for People With Previously Treated Chronic Lymphocytic Leukemia
South San Francisco, CA -- June 8, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Venclexta (venetoclax) in combination with Rituxan ... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 8, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Genentech ’s Rituxan (rituximab) for Pemphigus Vulgaris
South San Francisco, CA -- June 7, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Rituxan (rituximab) for the treatment of adults with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 7, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Mircera for Anemia Associated with Chronic Kidney Disease in Pediatric Patients on Dialysis
On June 7, 2018, the Food and Drug Administration approved methoxy polyethylene glycol-epoetin beta (Mircera, Vifor Pharma Inc.) for the treatment of pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 7, 2018 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Approves Fulphila (pegfilgrastim-jmdb), the First Biosimilar to Neulasta
HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, June 4, 2018 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 4, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Olumiant (baricitinib) 2 mg Tablets for the Treatment of Adults with Moderately-to-Severely Active Rheumatoid Arthritis
INDIANAPOLIS, June 1, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has approved the 2-mg dose of Olumiant (baricitinib), a once-daily... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 1, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Consensi (amlodipine and celecoxib) for Treatment of Hypertension and Osteoarthritis Pain
TEL AVIV, Israel, May 31, 2018 (GLOBE NEWSWIRE) -- Kitov Pharma Ltd. (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Consensi (amlodipine and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 31, 2018 Category: Drugs & Pharmacology Source Type: news

TherapeuticsMD Announces FDA Approval of Imvexxy (estradiol vaginal inserts) for the Treatment of Dyspareunia Due to Menopause
BOCA RATON, Fla., May 30, 2018 /PRNewswire/ -- TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women's healthcare company, today announced that the United States Food and Drug Administration (FDA) has approved Imvexxy (estradiol vaginal inserts)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 31, 2018 Category: Drugs & Pharmacology Source Type: news

Pfizer Announces U.S. FDA Approves Xeljanz (tofacitinib) for the Treatment of Moderately to Severely Active Ulcerative Colitis
Wednesday, May 30, 2018 - Pfizer Inc. announced today that the United States (U.S.) Food and Drug Administration (FDA) approved Xeljanz (tofacitinib) 10 mg twice-daily (BID) for at least eight weeks, followed by Xeljanz 5 mg BID or 10 mg BID, for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 30, 2018 Category: Drugs & Pharmacology Source Type: news

UCB Announces the Approval of Cimzia (certolizumab pegol) for Moderate-to-Severe Plaque Psoriasis
Brussels, Belgium – 28th May, 07:00 CEST – UCB announced today that the U.S. Food and Drug Administration (FDA) has approved extending the label for Cimzia (certolizumab pegol) to include a new indication in adults with moderate-to-severe plaque... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 28, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Palynziq (pegvaliase-pqpz) for the Treatment of Adults with Phenylketonuria
May 24, 2018 - The U.S. Food and Drug Administration today approved Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU). Patients with PKU are born with an inability to break down... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 24, 2018 Category: Drugs & Pharmacology Source Type: news

GSK Receives FDA Approval of Arnuity Ellipta for Asthma in Children From 5 Years of Age
London, UK 21 May 2018 --GSK today announced it has received approval from the US Food and Drug Administration (FDA) for the use of Arnuity Ellipta (fluticasone furoate) a once-daily inhaled corticosteroid (ICS) medicine for the maintenance... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 24, 2018 Category: Drugs & Pharmacology Source Type: news

Sun Pharma Announces FDA Approval of Yonsa (abiraterone acetate) to Treat Metastatic Castration-Resistant Prostate Cancer
MUMBAI& PRINCETON, N.J.& KING OF PRUSSIA, Pa. May 23, 2018 --(BUSINESS WIRE)--Sun Pharmaceutical Industries Ltd. and includes its subsidiaries and/or associate companies) and Churchill Pharmaceuticals, LLC. (Churchill) today announced that... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 23, 2018 Category: Drugs & Pharmacology Source Type: news

Lilly's Taltz (ixekizumab) Receives the First U.S. FDA Approval for Label Update to Include Data for Psoriasis Involving the Genital Area
INDIANAPOLIS, May 22, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label update for Taltz (ixekizumab) injection 80 mg/mL to include data in psoriasis... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 22, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Doptelet (avatrombopag) for Chronic Liver Disease Patients with Thrombocytopenia who are Undergoing a Medical Procedure
May 21, 2018 -- The U.S. Food and Drug Administration today approved Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Doptelet (avatrombopag) for Thrombocytopenia Patients with Chronic Liver Disease who are Undergoing a Medical Procedure
May 21, 2018 -- The U.S. Food and Drug Administration today approved Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Prolia (denosumab) for Glucocorticoid-Induced Osteoporosis
THOUSAND OAKS, Calif., May 21, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the use of Prolia (denosumab) for the treatment of glucocorticoid-induced osteoporosis (GIOP) in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Aimovig (erenumab-aooe) as a Preventive Treatment for Migraine
May 17, 2018 -- The U.S. Food and Drug Administration today approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 18, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Lokelma (sodium zirconium cyclosilicate) for the Treatment of Adults with Hyperkalemia
May 18, 2018 -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalemia in adults. Hyperkalemia is a serious condition... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 18, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Lucemyra (lofexidine hydrochloride) as the First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms
May 16, 2018 -- The U.S. Food and Drug Administration today approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While Lucemyra may lessen the severity of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Retacrit (epoetin alfa-epbx) as First Epoetin Alfa Biosimilar for the Treatment of Anemia
May 15, 2018 -- The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 15, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Expanded Indication for Truvada (emtricitabine and tenofovir disoproxil fumarate) for Reducing the Risk of Acquiring HIV-1 in Adolescents
FOSTER CITY, Calif.--(BUSINESS WIRE)--May 15, 2018-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 15, 2018 Category: Drugs & Pharmacology Source Type: news

UCB Announces Briviact (brivaracetam) Now Approved by FDA to Treat Partial-Onset (Focal) Seizures in Pediatric Epilepsy Patients
Atlanta, Georgia (U.S.)& Brussels (Belgium), 0700 CEST, 14 May, 2018: UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the company ’s newest anti-epileptic drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 14, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Subcutaneous Formulation of Actemra for use in Active Polyarticular Juvenile Idiopathic Arthritis
South San Francisco, CA -- May 14, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra ®... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 14, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Expands Approval of Gilenya (fingolimod) to Treat Multiple Sclerosis in Pediatric Patients
May 11, 2018 -- The U.S. Food and Drug Administration today approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the first FDA approval of a drug to treat MS in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 11, 2018 Category: Drugs & Pharmacology Source Type: news

Salix Receives FDA Approval for Plenvu, Next Generation 1-Liter Bowel Cleansing Preparation for Colonoscopies
BRIDGEWATER, N.J., May 7, 2018 /PRNewswire/ -- Salix Pharmaceuticals, Ltd. ( " Salix " ), one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases and a wholly owned... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 7, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Supplemental New Drug Application for Myrbetriq (mirabegron) for Use in Combination with Solifenacin Succinate for the Treatment of Overactive Bladder Symptoms
TOKYO, May 7, 2018 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., " Astellas " ) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 7, 2018 Category: Drugs & Pharmacology Source Type: news

Janssen Announces Darzalex (daratumumab) U.S. FDA Approval for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible
HORSHAM, PA, May 7, 2018 – The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Darzalex (daratumumab) in combination with Velcade (bortezomib)*, a proteasome... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 7, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Tafinlar + Mekinist for the Treatment of BRAF-Positive Anaplastic Thyroid Cancer
May 4, 2018 -- The U.S. Food and Drug Administration approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 4, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Portola Pharmaceuticals ’ Andexxa, First and Only Antidote for the Reversal of Factor Xa Inhibitors
SOUTH SAN FRANCISCO, Calif., May 03, 2018 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo], the first and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 3, 2018 Category: Drugs & Pharmacology Source Type: news

Kymriah (tisagenlecleucel) Receives Second FDA Approval to Treat Appropriate Patients with Large B-Cell Lymphoma
Basel, May 1, 2018 - Novartis today announced the US Food and Drug Administration (FDA) has approved Kymriah ® (tisagenlecleucel) suspension for intravenous infusion for its second indication - the treatment of adult patients with relapsed or... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 1, 2018 Category: Drugs & Pharmacology Source Type: news

Novartis Receives FDA Approval of Tafinlar + Mekinist for Adjuvant Treatment of BRAF V600-Mutant Melanoma
:Basel, April 30, 2018 - Novartis announced today that the US Food and Drug Administration (FDA) has approved Tafinlar ® (dabrafenib) in combination with Mekinist® (trametinib) for the adjuvant treatment of patients with melanoma with BRAF V600E or... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 30, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Jynarque (tolvaptan) to Slow Kidney Function Decline in Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease
April 24, 2018 -- TOKYO--(BUSINESS WIRE)--Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the U.S. Food and Drug Administration (FDA) has approved Jynarque (tolvaptan) as the first drug treatment to slow kidney function decline in adults at... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 24, 2018 Category: Drugs & Pharmacology Source Type: news

Once-Daily Trelegy Ellipta Gains Expanded Indication in the US for the Treatment of Patients with COPD
24 April 2018 -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the US Food and Drug Administration (FDA) has approved an expanded indication for Trelegy Ellipta (fluticasone... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 24, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Intravenous Formulation of Akynzeo (fosnetupitant/palonosetron) for Chemotherapy-Induced Nausea and Vomiting
Lugano, Switzerland April 20, 2018 – Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, today announces that the U.S. Food and Drug Administration (FDA) has approved the intravenous formulation of Akynzeo... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 20, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Tagrisso (osimertinib) as First-Line Treatment for EGFR-Mutated Non-Small Cell Lung Cancer
18 April 2018 -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 18, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Crysvita (burosumab-twza) for X-Linked Hypophosphatemia
April 17, 2018 -- The U.S. Food and Drug Administration today approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. XLH... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 17, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Provides Full Approval to Praxbind (idarucizumab), Specific Reversal Agent for Pradaxa
Ridgefield, Conn., April 17, 2018 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has provided full approval for Praxbind (idarucizumab), the specific reversal agent for Pradaxa (dabigatran etexilate... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 17, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Tavalisse (fostamatinib disodium hexahydrate) for Chronic Immune Thrombocytopenia
SOUTH SAN FRANCISCO, Calif., April 17, 2018 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that the U.S. Food and Drug Administration (FDA) approved Tavalisse (fostamatinib disodium hexahydrate) for the treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 17, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Vonvendi [von Willebrand factor (recombinant)] for Perioperative Management of Bleeding in Adult Patients with von Willebrand Disease
Cambridge, Ma. – April 17, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare disease, today announced the U.S. Food and Drug Administration (FDA) has approved Vonvendi [von Willebrand factor (recombinant)], a... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 17, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) Combination as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma
PRINCETON, N.J.--(BUSINESS WIRE) April 16, 2018 --Bristol-Myers Squibb Company (NYSE: BMY) today announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Afinitor Disperz (everolimus) for Tuberous Sclerosis Complex-Associated Partial-Onset Seizures
April 11, 2018 -- On April 10, 2018, the Food and Drug Administration approved everolimus tablets for oral suspension (Afinitor Disperz, Novartis Pharmaceuticals Corp.) for the adjunctive treatment of adult and pediatric patients aged 2 years and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 12, 2018 Category: Drugs & Pharmacology Source Type: news

Pacira Announces FDA Approval of Exparel as a Nerve Block to Produce Regional Analgesia
PARSIPPANY, N.J., April 06, 2018 (GLOBE NEWSWIRE) -- Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) to broaden the use of Exparel... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 6, 2018 Category: Drugs & Pharmacology Source Type: news

Rubraca (rucaparib) Approved in the U.S. as Maintenance Treatment of Recurrent Ovarian Cancer
BOULDER, Colo.--(BUSINESS WIRE)--Apr. 6, 2018-- Clovis Oncology, Inc. (NASDAQ:CLVS) today announced that the U.S. Food and Drug Administration (FDA) has approved Rubraca (rucaparib) tablets for the maintenance treatment of adult patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 6, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Bydureon (exenatide extended-release) for Use with Basal Insulin in Patients with Type 2 Diabetes with Inadequate Glycemic Control
April 3, 2018 AstraZeneca today announced the US Food and Drug Administration (FDA) has approved Bydureon (exenatide extended-release) for injectable suspension as an add-on therapy to basal insulin in adults with type 2 diabetes (T2D) with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 3, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Expands Approval of Blincyto (blinatumomab) to Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
March 29, 2018 -- The U.S. Food and Drug Administration granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 29, 2018 Category: Drugs & Pharmacology Source Type: news

Mylan Introduces Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) Triple Combo Once-Daily HIV Treatment in the U.S.
HERTFORDSHIRE, England and PITTSBURGH, March 28, 2018 /PRNewswire/ -- Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced that it will introduce in the U.S. a third cost-saving HIV combination. The U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 28, 2018 Category: Drugs & Pharmacology Source Type: news